Comparison of Laryngeal Masks in Urethral Cystoscopic Sur... | NCT04186455

Studies
Comparison of Laryngeal Masks in Urethral Cystoscopic Surgery Operations: a Prospective Randomized Clinical Study

NCT04186455

Sponsor

Kocaeli University

Status

Completed

Last Update Posted

Feb 8, 2022Actual

Enrollment

64Actual

Phase

Not Applicable

Conditions

Ureteral Calculi

Interventions

proseal
baska-mask

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 5, 2019Actual

Primary Completion Date

Feb 7, 2022Actual

Completion Date

Feb 7, 2022Actual

First Submitted Date

Nov 28, 2019

First Submission Date that Met QC Criteria

Dec 2, 2019

First Posted Date

Dec 4, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2022

Last Update Posted Date

Feb 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The use of Laryngeal masks are increased.This study aimed to compare lma pro seal and baska -mask in urethral retrograde sistoscopy operations.

Detailed Description

The use of Laryngeal masks are increased. Aimed to compare lma pro seal and baska -mask in urologic retrograde sistoscopy operations. ASA 1-2 80 subjects who is undergoing elective URS operations were enrolled in this prospective randomized clinical study. The demographic and airway characteristics of patients preoperatively and lam insertion times, nasogastric insertion times number of intubation attempts, fiberoptic grades from the lam, expired tidal volume, oropharyngeal leak pressures, peak and mean airway pressures preoperatively, minor complications like sore throat, hoarseness, dysphagia were recorded at the postoperative care unit.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
insertion time	Active Comparator	lma pro seal and basks-mask in patients undergoing ups	Device: proseal Device: baska-mask
oropharyngeal leak pressure	Active Comparator	lma baska-mask undergoing urs	Device: proseal Device: baska-mask

Interventions

Name	Type	Description	Arm Group Labels	Other Names
proseal	Device	laryngeal mask proseal	insertion time oropharyngeal leak pressure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
insertion time	insertion time of the laryngeal mask	20 seconds

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:18-65 years of age

undergoing elective urs operations
bmı<35
ASA I-II

Exclusion Criteria:<18 years of age

bmı>35
ASA III-IV

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kocaeli University Medical Faculty		Kocaeli			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014514	Ureteral Calculi

Ancestor Terms

ID	Term
D053039	Ureterolithiasis
D014515	Ureteral Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017214	Laryngeal Masks

Ancestor Terms

ID	Term
D007442	Intubation, Intratracheal
D058109	Airway Management
D013812	Therapeutics
D007440	Intubation

Browse Leaves

Not provided

Browse Branches

Not provided